The following data is part of a premarket notification filed by Biomet Spine with the FDA for Small Stature Spacers.
| Device ID | K063393 |
| 510k Number | K063393 |
| Device Name: | SMALL STATURE SPACERS |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | BIOMET SPINE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET SPINE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-06-25 |
| Summary: | summary |